The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- Prolonged ventilation > 24 hours
研究概览
简要总结
The purpose of this study is to identify measures of obesity, functional capacity, and specific biomarkers that may be predictive of obesity and post-operative outcomes.
详细描述
Background: Increasing levels of obesity worldwide have led to a rise in the prevalence of obesity-related complications including cardiovascular disease, diabetes, cancers etc. Health care providers believe that obesity has a negative effect on patients undergoing cardiac surgery, with overweight and obese patients being more likely to experience adverse post-operative outcomes. The body mass index (BMI) is the single most used measure for determining obesity classification in clinical practice, without accounting for a patient's level of cardiopulmonary fitness or muscle mass.
Study Design: Patients between the ages of 18 and 75 years undergoing elective cardiac surgery will be consented to participate in this prospective observational trial. Patients are invited to participate in measures of obesity, functional capacity and exercise capacity assessments, quality of life questionnaires, and blood and tissue sampling for biomarker analysis.
Endpoints: Measures other than BMI that could be predictive of short-term and long-term post-operative outcomes. Outcomes of interest include: prolonged length of ventilation, hospital length of stay and all-cause mortality.
Summary: The results of this trial will potentially identify an improved definition of fitness capacity for obese cardiac surgical patients and biomarkers alone or in combination that could identify the potential for adverse outcomes in patients undergoing cardiac surgery. This study will help clinicians better segregate and treat patients pre-operatively based on fitness levels and associated biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •· Provide informed consent
- •Male or female patients who are > 18 years of age
- •Patients must be scheduled to undergo elective, first-time cardiac surgery during routine scheduling times
排除标准
- •Patients who are > 75 years of age
- •BMI is less than 18.5 kg/m2 and classified as underweight according to the World Health Organization
- •Any non-elective first time cardiac surgery patient (eg. in-house urgent patients; emergent patients)
- •Any cardiac patients to undergo re-operation
- •Simultaneous participation in another study with an investigational study agent
结局指标
主要结局
Prolonged ventilation > 24 hours
时间窗: post-operative day (POD) 30
mechanical ventilation for more than 24 hours of invasive (via endotracheal tube or tracheostomy) and/or noninvasive (facial/nasal interface) methods of delivery
Prolonged Hospitalization
时间窗: post-operative day (POD) 30
A length of stay of more than 5 days
次要结局
- Respiratory complications(post-operative day (POD) 30)
- Re-operation for any cause(post-operative day (POD) 30 and 1 year post-op)
- Atrial fibrillation(post-operative day (POD) 30 and 1 year post-op)
- all cause mortality(post-operative day (POD) 30 and 1 year post-op)
- non fatal myocardial infarction(post-operative day (POD) 30 and 1 year post-op)
- Stroke(post-operative day (POD) 30)
- Post-operative length of stay and disposition on discharge(post-operative day (POD) 30 and 1 year post-op)
- Wound infection(post-operative day (POD) 30)
- Prolonged ICU length of stay(post-operative day (POD) 30)
研究者
Ansar Hassan, MD, PhD
Principal Investigator
Dalhousie University